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«Innovation expert clean rooms»®

Construction of a Prefabricated Modular Building for a Thermal Disinfection and Decontamination Station for Pathogenicity Groups III–IV Effluents

20.08.2021

Customer: Binnopharm JSC

INEX Group has officially launched the design phase for a state-of-the-art microbiological laboratory for Binnopharm JSC, a premier full-cycle Russian biopharmaceutical manufacturer. Known for its sophisticated R&D and the production of genetic-engineering drugs (including Hepatitis B vaccines), Binnopharm requires a facility that mirrors its commitment to global quality standards.

The new laboratory is engineered to function as a critical quality control hub. Its primary mission is the rigorous testing of Finished Dosage Forms (FDF) to ensure absolute sterility and microbiological purity before products reach the market.

[Image: Microbiological laboratory layout showing specialized zones for sterility testing and incubation]

Key Research & Monitoring Functions: The design accommodates a complex range of diagnostic and monitoring tasks essential for biopharmaceutical safety:

  • FDF Sterility Testing: Verifying the absence of microbial life in finished drugs and primary packaging.

  • Environmental Monitoring: Constant analysis of air quality, equipment surfaces, and cleanroom integrity within production zones.

  • Personnel Hygiene Audits: Systematic testing of specialized clothing and personnel hands to ensure the human factor does not compromise the sterile chain.

Engineering and Safety Excellence: The project integrates advanced architectural and technological solutions to create a seamless barrier against contamination. Special focus is placed on automated HVAC systems and pressure cascading, ensuring that the laboratory maintains its required cleanliness class under all operational conditions.

[Image: Personnel airlock and gowning procedure diagram for a Grade B cleanroom]